# K993684: Spinal Pad

- Pathway: 510(k) (Traditional)
- Applicant: Bioscan, Inc.
- Decided: Jul 19, 2000 after 261 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
174 later devices descend from it; 2 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K043317: Omnilux Plus (2005), 171 descendants of its own
- K050216: Omnilux Revive and Omnilux Plus (2005), 160 descendants of its own
- K060792: Illumimed (2006), 115 descendants of its own
- K083183: Aklarus Phototherapy System (2009), 91 descendants of its own
- K072459: Omnilux New-U (2008), 91 descendants of its own

## Indications for use
Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional Provides temporary relief of minor aches and pains in muscles and joints Aids in the relaxation of muscles Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief Provides a temporary increase in local blood circulation

Source page: https://510kreport.com/device/K993684
Methodology: https://510kreport.com/methodology